Study of the Choroidal Thickness Variations After Ingestion of RedBull® Energy Drink

NCT ID: NCT02856256

Last Updated: 2017-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-12
• Study Completion Date: 2017-05-29

Brief Summary

The choroid is a richly vascularized conjunctive tissue, providing the nutritive elements to the pigmentary epithelium and the photoreceptors of the retina. It drains 80% of the eye's blood. The choroidal thickness fluctuates according to the state of fullness of its constitutive vessels. The choroid and the neuroretina (separate by the pigmentary epithelium) are intimately linked and are subject to modifications during the ingestion of caffeine and taurine combined. Several authors have shown a significant decrease of the choroidal thickness lasting at least 4 hours after the ingestion of a small coffee. This decrease may be caused by caffeine's vasoconstrictor effect. Taurine is the most abundant amino acid in the retina. Recent studies have shown the importance of this amino acid in the physiology of both, retinal pigmentary epithelium and retinal ganglion cells.

RedBull® is an energizing drink, where one single 25 cl can contains 80 mg of caffeine (the equivalent of a coffee mug) and 1 g of taurine.

This pilot trial aims to study the variations of the choroidal thickness and to describe possible modifications within the pigmentary epithelium, due to the ingestion of caffeine and taurine. The results of this study will act as a reference for an ulterior trial aiming specific choroidal pathologies of young patients, such as the central serous chorioretinitis.

Conditions

Choroid

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

RedBull® energy drink

Group Type: EXPERIMENTAL

RedBull® energy drink

Intervention Type: DIETARY_SUPPLEMENT

Subjects consume 25 mL of RedBull® energy drink

Interventions

RedBull® energy drink

Subjects consume 25 mL of RedBull® energy drink

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Ages 18-45 years old
• subject under no medical treatment who can alter choroidal depth (sildenafil, diuretics, steroids, etc)
• Non smoker
• subject who has not ingested any caffeine within the 12 hours prior to the trial's inclusion
• subject well informed of the trial and having signed consent

Exclusion Criteria

• subject with retinal and/or choroidal abnormalities
• Diabetic subject
• Hypermetropia > +3 diopters and myopia < -3 diopters
• History of intra-ocular surgery or laser
• subject with a history of retinal pathologies
• Subject not affiliated to French social security
• Subject under juridical protection
• Pregnant woman

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fondation Ophtalmologique Adolphe de Rothschild

Paris, , France

Countries

France

References

Arej N, Azar G, Salviat F, Alonso AS, Zuber K, Metten MA, Salomon L, Vasseur V, Mauget-Faysse M. Study of choroidal thickness variations after ingestion of a taurine and caffeine-containing energy drink. Clin Nutr ESPEN. 2021 Jun;43:245-249. doi: 10.1016/j.clnesp.2021.04.007. Epub 2021 Apr 17.

Reference Type: DERIVED

PMID: 34024522 (View on PubMed)

Other Identifiers

MMT_2015_2

Identifier Type: -

Identifier Source: org_study_id